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Informed Consent in the Electronic Age

Published online by Cambridge University Press:  24 February 2021

Arnold J. Rosoff
Arnold J. Rosoff*
Affiliation:
The Wharton School, University of Pennsylvania, Leonard Davis Institute of Health Economics, University of Pennsylvania, University of Pennsylvania; Columbia Law School
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Extract

Dr. X, a urologist, has just told his patient, Mr. Y, a fifty-eight-year-old businessman, that he has prostate cancer. The revelation was difficult for both parties, but it did not come as a complete surprise because it had been preceded by a multistep diagnostic process. Although hoping for better, Mr. Y and his wife were expecting this bad news when they went into the doctor's office.

After offering some words of hope and encouragement, Dr. X tells the patient and his wife that, before they discuss any further the important choices that lie ahead in the treatment of Mr. Y's condition, he would like them to take time to review carefully the information contained in the CD-ROM program he has just handed them. The program, entitled “Living with a Diagnosis of Prostate Cancer,” is one of a library of such programs developed and marketed by a company specializing in computer-based patient education products.

Type
Articles
Information
American Journal of Law & Medicine , Volume 25 , Issue 2-3: Electronic Medical Information: Privacy, Liability & Quality Issues , 1999 , pp. 367 - 386
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1999

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References

1 George Orwell, Nineteen Eighty-Four 4-5 (Knopf Everyman's Library 1992) (1949). In the futuristic, totalitarian society envisioned in this classic political allegory, all citizens were constantly monitored by a system of television cameras operated by the government, euphemistically dubbed, “Big Brother.” See id.

2 Hippocrates, the celebrated Greek physician, best known for the famous Oath of Hippocrates (circa 400 B.C.), to which many new doctors still swear allegiance, is widely hailed as a founding father of the medical arts, although significant strides in medicine had already been made prior to his contribution. See Oath of Hippocrates (visited Apr. 14, 1999) <http://www.cirp.org/Iibrary/ethics/hippocrates>; see also Nuland, Sherwin B., Heroes of Medicine, Time, Fall 1997Google Scholar, at 6, 6 (citing Hippocrates as the founder of a medical tradition that emphasizes clinical observation and ethics).

3 This disruptive effect may not be permanent. Although the introduction of a closed-panel managed care plan may break up existing relationships between providers and subscribers, there is potential for durable, long-standing relationships to form once persons have joined health plans and chosen primary care physicians (PCPs) to manage their care. In fact, the gatekeeper aspects of the PCP's role, such as managing the member's access to other providers, may over time form the basis for a bond stronger than that found in traditional, fee-for-service medicine.

4 See Grumbach, Kevin et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 New Eng. J. Med. 1516, 1519 (1998)CrossRefGoogle Scholar.

5 See, e.g., Sheldon, Jonathan, Letters, Faxes & E-Mail, Denver Post, Feb. 10, 1999Google Scholar, at Bio, available in 1999 WL 7875449 (noting that under the health maintenance organization system, waiting times are up, although the length of each visit is down).

6 See Miller, Franklin G. et al., Clinical Pragmatism: John Dewey and Clinical Ethics, 13 J. Contemp. Health L. & POL'Y 27, 34 (1996)Google Scholar.

7 See Berg, Paula, Toward a First Amendment Theory of Doctor-Patient Discourse and The Right to Receive Unbiased Medical Advice, 74 B.U. L. Rev. 201, 225-26 (1994)Google Scholar; Jeffrey, Nancy Ann, A Little Knowledge … Doctors are Suddenly Swamped with Patients Who Think They Know a Lot More Than They Actually Do, Wall St. J., Oct. 19, 1998Google Scholar, at R8 (quoting a doctor as saying that physicians “can't keep up this image of being all-knowing anymore” because of the amount of health information now available on the Internet).

8 See, e.g., Miller, Frances H., Health Care Information Technology and Informed Consent: Computers and the Doctor-Patient Relationship, 31 Ind. L. Rev. 1019, 1020 & n.10 (1998)Google Scholar; see also, e.g., Petersen, Andrea, Home Remedies: As Medical Care Gets More Impersonal, Patients are Seeking Advice from Radio, TV and the Internet, Wall St. J., Oct. 19, 1998Google Scholar, at R4 (noting that the volume of medical information has increased dramatically in recent years); Quick, Rebecca, Click Here: Venture onto the Web, and You Immediately Understand the Meaning of 'Information Overload', Wall St. J., Oct. 19, 1998Google Scholar, at RIO (listing health-related Internet addresses and giving a brief description of each site's contents); Jeffrey, supra note 7, at R8 (discussing the burden placed on doctors by patients who self-diagnose their illness using information found on the Internet).

9 See Ferguson, Tom, Digital Doctoring Opportunities and Challenges in Electronic Patient-Physician Communication, 280 Jama 1361, 1361 (1998)CrossRefGoogle Scholar.

10 Only about 18 million Americans eighteen or older, which represents a bit under seven percent of the U.S. population in 1997, used the Internet to search for health or medical information. See id.; Estimates of the Population of the U.S., Regions, and States by Selected Age Groups and Sex (visited Apr. 18, 1999) <http://www.census.gov/population/estimates/state/97agesex.txt>. In addition, the American Medical Association (AMA) has conducted a large-scale survey in 1997, titled A Benchmark Study On Physicians' use of the World Wide Web, of U.S. physicians' use of computers and Internet technology. More information about this study can be obtained by contacting AMA's Circulation Service at (312) 464-5954. Telephone Conversation with Ray Helm, Sales Account Manager, American Medical Association, Circulation Service (May 13, 1999).

11 A difficult and important question not addressed in this Article is what the social impact may be when the dynamics of doctor-patient relations are increasingly driven by information technologies not available equally to all users of the health care system.

12 Health professionals in institutional settings have an edge on “getting wired.” See Serb, Chris, Techtravails: Computer Pros Have Seen the Future—and They 're Plenty Worried about How They '11 Get There, Hosp. & Health Networks, Apr. 20, 1998Google Scholar, at 39. Furthermore, in the 1998 Healthcare Information and Management Systems Society's (HIMSS) annual survey, 95% of hospitals and health systems responded that they use the Internet, a figure that is up from 87% in 1996. See id. at 40.

13 See, e.g., Avedon, Arato v., 858 P.2d 598, 607 (Cal. 1993)Google Scholar.

14 See Schloendorff, v. Society of New York Hosp., 105 N.E. 92, 93 (1914)Google Scholar.

15 Id.

16 For an elaboration on the history and requirements of the informed consent doctrine, see generally Miller, supra note 8; Schuck, Peter H., Rethinking Informed Consent, 103 Yale L. J. 899 (1994)CrossRefGoogle Scholar; Merz, Jon F. & Fischhoff, Baruch, Informed Consent Does Not Mean Rational Consent: Cognitive Limitations on Decision-Making, 11 J. Legal Med. 321 (1990)Google Scholar; Arnold J. Rosoff, Informed Consent: A Guide for Health Care Providers (1981).

17 In-Forms, one of the earliest companies in this field, still sells preprinted pads with procedure-specific consent forms for a variety of procedures. See In-Forms: Medical Risk Disclosure for Informed Consent (visited May 9, 1999) <http://www.in-forms.com/comp.htm>. Compared with the prices of the more sophisticated devices described in this Article, the price of $9 per pad of 50 forms seems rather inexpensive. See id. at <http://www.in-forms.com/iprice.htm>. Another company sells software that prints provider-customized forms as part of a comprehensive patient education/informed consent package for plastic surgery offices. See Inform Software, Inc. (visited Apr. 6, 1999) <http://www.informsoftware.com>.

18 See, e.g., Faden, Ruth, Disclosure and Informed Consent: Does it Matter How We Tell It?, 5 Health Educ. Monographs 198, 200 (1977)CrossRefGoogle Scholar (comparing the effectiveness of disclosure mediums chosen by physicians, including the use of pamphlets, to provide information to their patients).

19 The tradition of keeping patients in the dark about their condition and the treatment they were about to receive goes back a very long time. Hippocrates is said to have counseled that patients should be kept ignorant of the mysterious treatments that would be used on them in order to enhance the treatment's placebo effect. See Medicine at the Crossroads—the Code of Silence (Thirteen/Wnet & BBC-TV 1993).

20 The most likely cause of incomplete information is the occurrence of new developments in medical knowledge since the prepackaged disclosure was prepared. The challenge of keeping disclosure devices current is discussed later. See infra Part III.A.

21 See Rosoff, Arnold, Consents, in Treatise on Health Law § 17.07[l][ii], at 17-1, 17-86Google Scholar (Michael G. McDonald et al., eds. 1996) [hereinafter Treatise on Health Law]. The author has argued against such an overreaction. A device that provides some protection should not be rejected simply because it cannot provide absolute protection. See id.

22 On the use of videotape as a means of patient education, see generally Barbour, Galen L. & Blumenkrantz, Michael J., Videotape Aids Informed Consent Decision, 240 Jama 2741 (1978)Google Scholar. One of the first companies to produce such products was Advise & Consent, which formed HealthStat Productions, Inc. to produce patient educational videotapes. See Healthstat—Health Status: Concepts, Measures, and Applications (visited Apr. 18, 1999) <http://www.heaIthstatprod.com/series_one.php3>. Although videotapes are now last-generation technology, they are still commonly available as a means of educating patients. Lange Productions, for example, offers programs in the areas of “breast medicine,” cardiology, imaging, oncology, “prostate medicine” and women's health. See Lange Productions (visited Apr. 18, 1999) <http://www.langeproductions.com/Catalog>.

23 Moreover, there were compatibility issues among video cassette recorders. Doctors wishing to provide videotapes for patients' home use have to consider incurring the extra expense of buying them in both VHS and the now obsolete BetaMax formats.

24 The author is aware of no studies or reports examining how faithfully this protocol was observed. Particularly lacking are inquiries into the patient's opportunity to ask questions and the completeness of the explanations and answers supplied by the physician.

25 Another aspect of the comprehension problem was that the videotape was the same for everyone and, thus, had to be designed to a common level of comprehension ability, presumably pegged at the lowest common denominator. Moreover, patients had to proceed in a lock-step, linear fashion through the tape, in some cases wasting time or losing interest because they were viewing material with which they were already familiar.

26 2 President'S Commission for the Study of Ethical Problems in Medicine and Behavioral Research, Making Health Care Decisions 87 (1982).

27 See Wash. Rev. Code Ann. § 7.70.060 (West 1998) (placing the burden of rebutting the presumption of informed consent on patients who have signed a consent form); see also Descant v. Administrators of the Tulane Educ. Fund, 706 So. 2d 618, 632-33 (La. Ct. App. 1998) (holding that a patient who has signed a consent form is presumed to understand the risks disclosed, but may rebut the presumption with a showing of misrepresentation or inadequate disclosure); Brown v. Dahl, 705 P.2d 781, 788 (Wash. Ct. App. 1985) (holding that deficiencies in a consent form can rebut the presumption of informed consent). Instead, the legal inquiry has been whether the doctor has “disclosed material information, including reasonable alternative therapy … in terms that a reasonable doctor would believe a reasonable patient... would understand.” See Descant, supra, at 631.

28 Canterbury v. Spence, 464 F.2d 772, 780 n.15 (D.C Cir. 1972). The court's full explanation on this point is as follows:

In duty-to-disclose cases, the focus of attention is more properly upon the nature and content of the physician's divulgence than the patient's understanding or consent. Adequate disclosure and informed consent are, of course, two sides of the same coin— the former a sine qua non of the latter. But the vital inquiry on duty to disclose relates to the physician's performance of an obligation, while one of the difficulties with analysis in terms of “informed consent” is its tendency to imply that what is decisive is the degree of the patient's comprehension. As we later emphasize, the physician discharges the duty when he makes a reasonable effort to convey sufficient information although the patient, without fault of the physician, may not fully grasp it … . Even though the factfinder may have occasion to draw an inference on the state of the patient's enlightenment, the factfinding process on performance of the duty ultimately reaches back to what the physician actually said or failed to say. And while the factual conclusion on adequacy of the revelation will vary as between patients—as, for example, between a lay patient and a physician-patient—the fluctuations are attributable to the kind of divulgence which may be reasonable under the circumstances.

Id.

29 Led by the landmark Canterbury case, a large number of the informed consent cases decided in the 1970s called for disclosure of information beyond what physicians traditionally had provided their patients and beyond that previously required by the law. These cases measured the physician's disclosure duty by what information patients could reasonably be expected to consider material, rather than by what physicians customarily told their patients. See, e.g.. Miller v. Kennedy, 522 P.2d 852, 860 (Wash. Ct. App. 1974) (holding that the scope of duty to disclose information concerning the treatment proposed, alternative treatments and the risks of each course of action and of no treatment at all is measured by the patient's need to know); Cross v. Trapp, 294 S.E.2d 446, 454 (W. Va. 1982) (holding that whether a doctor has obtained informed consent from a patient depends on “whether a reasonable person in the patient's position would have withheld consent to [a medical procedure] had all material risks been disclosed”). On the distinction between the “doctor-based” and “patient-based” standards of disclosure, and the implications of using the broader definition of physicians' informed consent duties, see Canterbury, 464 F.2d at 786-88; Treatise on Health Law, supra note 21, § 17.03[3], at 17-32 to 17-34.

30 See, e.g., Garry, Tom, New Malpractice Armor Cus torn-Made for You, OBG MGMT., April 1995Google Scholar, at 26, 26 (describing a CD-ROM-based interactive system that provides extensive explanations of common obstetric and gynecologic conditions and procedures).

31 See What is ACOG PACE−? (visited Apr. 18, 1999) <http://www.acogpace.com>. The Patient Advise and Consent Encounter (PACE) was introduced at the American College of Obstetrics and Gynecology's (ACOG) annual meeting in May 1995. See Garry, supra note 30, at 26. The first system was installed in a physician's office in June 1995. See Electronic Correspondence with Michael Talarico, Director of Operations, ACOG-PACE− (Apr. 8, 1999). The system is also the first to have the endorsement of a national medical specialty society. See Garry, supra note 30, at 29.

32 See What is ACOG PACE−?, supra note 31.

33 See id. at <http://www.acogpace.com/ap02prod.html>.

34 See id. at <http://www.acogpace.com/apmod07.html>.

35 See id. at <http://www.acogpace.com/apmod09.html>.

36 Earlier versions of the PACE system used a videotape keyed into a computer program and required special, expensive equipment to accomplish this interaction. The current version, on the other hand, can be used on most current multimedia computers. See What is ACOG PACE−?, supra note 31, at <http://www.acogpace.com/ap06spec.html>. The refinements in the PACE product reflect how the state of the art is advancing generally.

37 See What is A COG PA CE−?, supra note 31.

38 See id.

39 See Garry, supra note 30, at 26-27.

40 See Baum, Neil, Patient Communication in the Era of Managed Care, COST & QUALITY, Oct. 1998, at 29Google Scholar; Priluck, Ira A. et al., What Patients Recall of the Preoperative Discussion after Retinal Detachment Surgery, 87 AM. J. Ophthalmology 620, 622-23 (1979)Google Scholar; Robinson, George & Merav, Avram, Informed Consent: Recall by Patients Tested Postoperatively, 22 Annals of Thoracic Surgery 209, 209 (1976)CrossRefGoogle Scholar.

41 See Garry, supra note 30, at 27.

42 When first introduced, the PACE system—marketed as an integrated package including the computer, touchscreen monitor, other hardware required for an in-office learning station and a complete set of CD-ROM software—cost $10,000 to buy or $250 per month to lease. See id. Now that physicians' offices more commonly have computers capable of playing CD-ROMs, the PACE disks can be purchased separately from the hardware, thus greatly reducing the overall cost. The complete set of PACE CD-ROM disks currently sells for $1,995 and contains the following 16 modules: Annual Gynecological Exam, Birth Control, Natural Family Planning, Breast Lumps, Dilatation and Curettage, Hysterectomy, Laparoscopy, Tubal Sterilization, Abnormal Pap Test Results: ASCUS, Abnormal Pap Test Results: Dysplasia, Abnormal Pap Test Results: Cancer, Introduction to Pregnancy, Monitoring Your Pregnancy, Preparation for Labor, Labor and Delivery, and Vaginal Birth After Cesarean. See What is ACOG PACE−?, supra note 31, at <http://www.acogpace.com/ap02prod.html>. Individual modules sell for $200 each, and the hardware can still be purchased or leased from PACE. See id. at <http://www.acogpace.com/ap06spec.html>. By contrast, interactive modules from the Patient Education Institute (PEI) at the University of Iowa cost $495 each. See X-Plain Catalog (visited Apr. 18, 1999) <http://www.patient-education.com/products/X-Plain/index.html>.

43 See Baum, supra note 40, at 30. The list of providers includes Dialog Medical, Lippincott-Raven, Clinical References Systems, Micromedix, Medifor, PEI and In-Form Software. See id. Reflecting the litigation concerns that drive this development, documentation of the computerized patient education interaction is one of the services offered to providers as part of the X-Plain system marketed by the University of Iowa's PEI. See Documentation Services (visited Apr. 18, 1999) <http://www.patient-education.com/services/Services/documentation.html>. For a monthly flat fee, PEI will maintain, for each X-Plain station, confidential computer records of each patient interaction for 10 years or more, certify in writing that the patient completed the module and, if necessary, testify in support of the authenticity and accuracy of its records regarding the patient's completion of the module. See id.

44 See Healthcare Information and Management Systems Society (visited May 13, 1999) <http://www.himss.org> (providing information on HIMSS and its annual conferences).

45 See supra notes 42-43.

46 See Uro Doc Categories (visited Apr. 18, 1999) <http://www.dialogmedical.com/uro_cat.htm>.

47 These products are less expensive in terms of price relative to the range of functions they can perform. For example, Dialog Medical's Urology Discussion CD-ROM, capable of generating over 600 urology-specific documents, customized to the provider's practice, see Urology Discussion: Informed Consent and Patient Education (visited Apr. 18, 1999) <http://www.dialogmedical.com/urology.htm>, sells for $399, see Order Form (visited Apr. 18, 1999) <http://www.dialogmedical.com/contacti.htm>. Similar programs are available from this vendor, such as programs in cardiology and gynecology. See Prod Desc (visited Apr. 18, 1999) <http://www.dialogmedical.com/healthca.htm>.

48 See, e.g., Mutual Ins. Corp. of America, Product & Services Frame: Computerized Patient Records (visited May 9, 1999) <http://www.mpmlc.com/product_services/riskmgmt/cpatientrec.htm> (listing approved software programs for computerized patient records and patient information systems that physicians may use to become eligible for premium credits from the insurer).

49 For example, PEI sells the complete computer hardware necessary to run its X-Plain system for $2,995. See X-Plain Catalog, supra note 42, at <http://patient-education.com/products/X-Plain/index_hardware.html>. A kiosk station to contain the hardware more attractively sells for an additional $1,995. See id.

50 Given a cost of $495 per module (PEI), or even $200 (PACE), physicians may be reluctant to invest in a module they do not expect to use very often. See supra note 42 (discussing cost of interactive modules).

51 Courts have, so far, been unwilling to hold as a matter of law that a physician is obligated to give specific, detailed statistical information on a patient's prognosis or other aspects of the treatment undertaken. See Arato v. Avedon, 858 P.2d 598, 605 (Cal. 1993); Johnson v. Kokemoor, 545 N.W.2d 495, 508 (Wis. 1996). However, as Frances Miller notes, courts are increasingly open to requiring more detailed information about the treatment, the provider, and the probability of successful treatment. See Miller, supra note 8, at 1035.

52 PEI's X-Plain system, for example, contains hundreds of software titles covering 16 medical specialties. See X-Plain Catalog, supra note 42.

53 The assumption here is that the vendor charges a flat fee annually to keep the information updated. Obviously, if the client had to bear the extra cost each time a new CD-ROM was issued, it would be a different story; but passing the financial burden of frequent updates on to the consumer might cut into the service's marketability.

54 Online services are accessed through two basic types of communications channels: (1) closed, proprietary networks and (2) the Internet, a universal, public access network. For purposes of the discussion herein, the technical distinction between the Internet and World Wide Web is insignificant. The Internet, which allows low-cost access from anywhere in the world, is fast becoming the preferred medium for accessing online information services. However, its fluid, open access nature raises a new dimension of legal risk. Because the Internet allows easy movement from one site to another site maintained by a different party, a visitors might easily be confused as to the source of the data they are accessing. This confusion could affect allocation of liability for harm caused by the information provided electronically.

Before use of the Internet became so widespread, online services were accessed via closed, proprietary networks. Once connected, using a password or other device to gain access, subscribers to that service could access only the data supplied by that service. If subscribers relied to their detriment on that data, knotty questions about liability might arise, but uncertainty about the source of the data is unlikely to be a confounding factor in the liability analysis. On the liability of those who maintain websites providing information and advice generally, Nicolas P. Terry, Cyber-Malpractice: Legal Exposure for Cybermedicine, 25 AM. J.L. & MED. 327,349-58.

Nowadays, use of the Internet complicates this situation. If a visitor to an Internet site is harmed by inaccurate or misleading information obtained there, a key issue in assigning responsibility could be whether the visitor knew, or should have known, what the source of the information was. Internet sites commonly contain links to other sites, which may or may not be maintained by the same data provider. As a visitor surfs from one site to another, it is easy to lose track of the data source. This is particularly the case where one site links to another site but displays the second site within a frame established by, and recognizable as belonging to, the first site. See, e.g.. Total News (visited May 13, 1999) <http://www.totalnew.com>; drkoop.com: “Your Trusted Health Network" (visited May 13, 1999) <http://www.drkoop.com>.

Many sites have a disclaimer announcing to visitors that the provider of that site accepts no responsibility for information the visitor may obtain by going to a linked site not maintained by that provider. These disclaimers, although often elaborate, may also be obscure and easily overlooked. Total News, for example, requires the visitor to click on an unobtrusive link button on its web page, labeled “terms of service,” to get to the disclaimer. See Total News, supra. Similarly, Glaxo Wellcome's website for its cancer drug Navelbine contains the following disclaimer:

Certain links on this site lead to resources located on servers maintained by third parties over whom Glaxo Wellcome Inc. has no control. As such, Glaxo Wellcome Inc. makes no representation as to the accuracy or any other aspect of the information contained on such servers.

See Copyright Info for Glaxo Wellcome Inc. (visited May 13, 1999) <http://www.gw-navelbine.com/copyrite.htm>. However, this legend is found within a whole page of verbiage, see id., and accessed by clicking on a link on the site's main page labeled “Please read our legal disclaimer and trademark information.” See Glaxo Wellcome, USA (visited May 13, 1999) <http://www.gw-navelbine.com>. It is questionable whether a visitor to the site would notice this link, would click on it and would necessarily notice the language quoted above and grasp its significance.

Although it is possible to design a site border protocol that requires visitors to click on an acknowledgment that they are leaving the site before doing so, such exit controls are apparently uncommon. There is no standard way of delineating website borders. Until protocols for this become established and, more important, until they are tested and found adequate in the courts, there will continue to be liability concerns for physicians using the Internet to supplement patient education.

55 A substantial body of case law, for example, holds that hospitals and other health care institutions do not have responsibility for assuring that the patient is sufficiently informed. See, e.g., Ward v. Lutheran Hosp. & Homes Soc'y of America, Inc., 963 P.2d 1031, 1033 (Alaska 1998) (holding that a hospital's mere status as a health care provider was insufficient to trigger the duty of informed consent when it was the patient's physician, and not the hospital, who ordered the blood transfusion); Lincoln v. Gupta, 370 N.W.2d 312, 318 (Mich. Ct. App. 1985) (holding that the treating physician, as opposed to the hospital, had the duty to warn patients of the risks associated with catheterization); Geise v. Stice, 567 N.W.2d 156, 164 (Neb. 1997) (holding that imposing a general duty on all entities meeting the statutory definition of health care provider would interfere unduly with the physician-patient relationship and would be more disruptive than beneficial for the patient); Fiorentino v. Wenger, 227 N.E.2d 296, 301 (N.Y. 1967) (holding that a hospital typically “does not share and should not share in the responsibilities to advise patients of the novelty and risks attendant on the procedure”); Cox v. Haworth, 283 S.E.2d 392, 395-96 (N.C. Ct. App. 1981) (holding that hospital had no duty to inform the plaintiff of risks and procedures to be used in surgery or to secure his informed consent when the plaintiff hired his private physician to perform the surgery); Cross v. Trapp, 294 S.E.2d 446, 458-59 (W. Va. 1982) (concluding that hospital will not be held liable for failing to obtain patient's informed consent where the patient asserted that a medical treatment, done without his consent, was performed by a privately retained physician). One state has articulated the same position through legislation. See Ohio Rev. Code Ann. § 2317.54 (Banks-Baldwin 1998) (providing that “[n]o hospital, home health agency, or provider of a hospice care program shall be held liable for a physician's failure to obtain an informed consent from his patient prior to a surgical or medical procedure or course of procedures, unless the physician is an employee of the hospital, home health agency, or provider of a hospice care program”). For a general discussion on this topic, see Note, Hospital Corporate Negligence Based Upon a Lack of Informed Consent, 19 Suffolk U. L. Rev. 835 (1985) (advocating that courts should require hospitals to ensure that physicians obtain their patients' informed consent).

56 See Barry R. Furrow Et Al., Health Law: Cases, Materials, and Problems 397-99 (3d ed. 1997); see also Chouinard v. Marjani, 575 A.2d 238, 242 (Conn. App. Ct. 1990) (finding that the plaintiff's use of the battery doctrine to hold a surgeon liable for performing bilateral breast surgery when the patient only consented to surgery on her left breast stated a cognizable cause of action).

57 See Miller, supra note 8, at 1019.

58 See Terry, supra note 54.

59 See id. It is not clear that Nicolas Terry's liability analysis would necessarily hold in a context where the physician directing the patient to the website, online service or CD-ROM has a contractual relationship with the provider of that information. See infra note 63 and accompanying text.

60 See Miller, supra note 8, at 1038 n.l 15 (citing relevant case law).

61 Although it is well established that one can waive his or her rights, even constitutional ones, if the waiver is knowing and voluntary, see Miranda v. Arizona, 384 U.S. 436, 444 (1966), the law leans against finding a waiver unless there is clear evidence that the party in question had adequate knowledge and the act was truly voluntary. See id. at 475. Moreover, the law disfavors waivers, disclaimers and other exculpatory provisions where there is a public interest to be served in protecting the rights of consumers and users of public facilities. See Tunkl v. Regents of Univ. of Cal., 383 P.2d 441, 443 (Cal. 1963) (in bank); Restatement (Third) of Torts § 18 (1998). But see Restatement (Third) of Torts § 18 cmt. d (suggesting that product purchasers who possess adequate knowledge and sufficient bargaining power adequate to protect their interests may contract with product sellers “to accept curtailment of liability in exchange for concomitant benefits”). On balance, it seems possible, albeit unlikely, that the waiver argument stated in the text would hold.

62 This Article does not discuss the intriguing but complex question of whether there might be strict products liability under Restatement (Third) of Torts section 402A for defective information contained in software programs. The crux of the issue is whether the supplier of the patient education device, the CD-ROM or the online program is selling a product, thus triggering the application of § 402A, or is, instead, providing a service, which would implicate general negligence principles. See generally Terry, supra note 54; Miyaki, Patrick T., Comment, Computer Software Defects: Should Computer Software Manufacturers Be Held Strictly Liable for Computer Software Defects?, 8 Santa Clara Computer & High Tech. L.J. 121 (1992)Google Scholar (arguing that a computer software manufacturer should not be held liable under a strict products liability theory for software defects); Lawrence, Diane B., Strict Liability, Computer Software and Medicine: Public Policy at the Crossroads, 23 Tort & Ins. L.J. 1 (1987)Google Scholar (analyzing the harmful social and economic effects that are likely to result from applying strict liability theory to medical software). Should it make a difference in this regard whether the information is supplied via a CD-ROM rather than an online service? A CD-ROM obviously looks more like a product than does an information transmission through one of the other mediums.

63 That is, providers of the information service could agree that if physicians were sued, the vendors would cover the physicians' expenses incident thereto. Such an engagement by the maker presumably would not shield physicians from liability to patients, but would only provide reimbursement for physicians after the fact. Of course, the contractual agreement could also point in the other direction, with suppliers of the informational devices disclaiming liability and requiring the doctors to acknowledge that they are responsible for informing the patient. This is the approach used by Dialog Medical, which sells a line of software applications for patient education and related purposes. See Patient Education and Informed Consent (visited Apr. 10, 1999) <http://www.dialogmedical.com/healthca.htm>. A physician installing its CD-ROM-based “Urology Discussion” program, for example, must click on an acknowledgment button signifying acceptance of the following disclaimer:

This software, Urology Discussion, is designed as a tool to assist physicians in managing their offices and in providing information to patients regarding the diagnosis and treatment of urologic disorders. Each physician or member of a physician's staff who uses this software is responsible for reviewing the information provided in the software and exercising their independent clinical judgment as to the accuracy and completeness of that information when advising individual patients, using their medical training and experience and considering the unique characteristics of those patients. Each physician is also responsible for determining whether the information provided in this software complies with the requirements of laws of the state in which the physician practices and the guidelines of any institution with which the physician may be affiliated.

For a demonstration copy of the “Urology Discussion” CD program, see Dialog Medical, My Mail Form: Request a Demo Program (visited May 8, 1999) <http://www.dialogmedical.com/feedback.html>.

64 Cf Tunkl v. Regents of Univ. ofCal., 383 P.2d 441, 448-49 (Cal. 1963) (en banc) (declaring void as against public policy an exculpatory clause in a charitable hospital's admission consent form releasing it from any liability for negligence); Shorter v. Drury, 695 P.2d 116, 119-20 (Wash. 1985) (en banc) (holding that a release of a physician from liability is not against public policy when it only exculpates the physician from liability for injury or death arising from the voluntary decision of his patient, a Jehovah's Witness, to decline a proffered blood transfusion).

65 An analogy can be found in the reasoning used by some courts to support the “captain of the ship” doctrine, although this doctrine is generally on the wane in American jurisprudence. See Price, Stephen H., The Sinking of the “Captain of the Ship”, 10 J. Legal Med. 323, 324 (1989)Google Scholar. For example, the court in Schultz v. Mutch said: a second, cogent and still pertinent justification for the doctrine … [is] the special relationship between a vulnerable hospital patient and the physician chosen by that patient… . [The] patient has chosen a physician, presumably based on faith in his competence and expertise. The patient reasonably expects the doctor to oversee her care and to look out after her interests while in and immediately pending surgery. 211 Cal. Rptr. 445, 450 (1985). An analogy might also be drawn to the “corporate practice of medicine” doctrine, which seeks to focus responsibility for patient care only on flesh-and-blood professionals. See Rosoff, Arnold J., The Business of Medicine: Problems with the “Corporate Practice” Doctrine, 17 Cumb. L. Rev. 485, 490 (1987)Google Scholar; Wiorek, John, The Corporate Practice of Medicine: An Outmoded Theory in Need of Modification, 8 J. Legal Med. 465, 485-86 (1987)Google Scholar.

66 See supra note 24 and accompanying text.

67 See Jay Katz, the Silent World of Doctor and Patient 2 (1984). 68 See id. at 1-29 (discussing the historical evolution of the informed consent doctrine).

69 Gresham's law is “the observation in economics that 'bad money drives out good.'” 5 The new Encyclopedia Britannica 489 (15th ed. 1998). Although Sir Thomas Gresham was not the first to propose this economic principle, economist H.D. MacLeod coined the term “Gresham's Law.” See id. As Gresham observed, “[i]f two coins have the same nominal value but are made from metals of unequal value, the cheaper will tend to drive the other out of circulation.” See id.

70 See Katz, supra note 67, at 98-103.

71 Under the “extension doctrine,” a physician has an implied, emergency authority to go beyond the limits of the patient's express consent when, in the course of agreed treatment, an unexpected complication is encountered and the patient, under the circumstances, cannot be consulted. See Kennedy v. Parrott, 90 S.E.2d 754, 759-60 (N.C. 1956). In such circumstances, however, the physician is expected to adhere to any limitations he knows, or reasonably should expect, the patient would impose if he were able to speak on the subject. See id.

72 See Gregory, Dorothy R., Medical Malpractice Prevention, in Legal Medicine 177, 182Google Scholar (Cyril H. Wecht ed. 1982); Arthur H. Bernstein, Avoiding Medical Malpractice 25 (1987); see also Baum, supra note 40, at 30 (recalling studies that noted improved physician patient communication as the most effective way to prevent malpractice lawsuits).

73 A study by Debra Roter of Johns Hopkins University in the mid 1970s demonstrated that giving patients information about their upcoming treatment before they met with the physician to discuss it increased rather than decreased the amount of time spent by the physician. See Roter, Debra L., Patient Participation in the Patient-Provider Interaction: The Effects of Patient Question Asking on the Quality of Interaction, Satisfaction, and Compliance, 50 Health Educ. Monographs 281, 301 (1977)Google Scholar. Patients, empowered by the initial infusion of knowledge, were able to formulate more and better questions and engage the physicians in a higher level of exchange about their care. See id. at 299.